Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management s
FDA device recall Z-0237-2024 · posted 2023-11-06 · Open, Classified
Recall details
- Recalling firm
- CHANGE HEALTHCARE CANADA COMPANY
- Reason for recall
- Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.
- Action taken
- Field Safety Notice was distributed to all consignees on10/12/2023 by email. The notice explained the issue, potential risk to the patient, and directed users to to check the CHRS Exception Tracker on a regular basis, as failed updates will be listed with details on the failure. Recommended actions to take on potentially affected data: Impacted data can be identified by using the CHRS Exception Tracker. Customers are advised to review records of recent updates from CHRS to external systems and manually update any changes to study records that may have been missed. Change Healthcare will install a software update.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- LLZ
- Quantity affected
- 282 units
- Distribution
- US, Canada, Ireland, Saudi Arabia, France, UK
- Date initiated
- 2023-10-12
- Date posted
- 2023-11-06
- Location
- Richmond, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MCKESSON RADIOLOGY (K140909) | Mckesson Medical Imaging Company | 2014-07-02 |